Starch-Loaded Pellets are pharmaceutical multiparticulate pellets in which starch forms an important component of the pellet matrix or carrier system. Starch is a naturally derived carbohydrate polymer identified by CAS 9005-25-8 and represented by the general formula (C₆H₁₀O₅)n.
Research has demonstrated the preparation of starch-based pellets using different starch types and formulation components, with pellet properties influenced by the starch type, active ingredient, additives and processing method. The resulting pellet characteristics can include controlled particle size, mechanical stability and formulation-dependent release behaviour.
The term “starch-loaded” should be distinguished from “starch-containing.” Starch-loaded pellets generally indicate a pellet system in which a defined formulation component has been incorporated into or loaded onto a starch-based pellet matrix. The actual starch loading percentage and composition must therefore be taken from the specific finished-product specification rather than assumed from the CAS material.
Commercial starch pellets are reported as white, spherical, free-flowing pellets, with one current commercial specification reporting 0.30–1.50 mm particle size, 0.40–0.60 g/mL bulk density, 0.60–0.80 g/mL tapped density, ≤5.0% moisture, pH 5.0–7.0 and ≤0.5% ash. These values are reference specifications and should not automatically be published as SDP's own COA limits.
Starch-Loaded Pellets can be considered for:
The final characteristics of Starch-Loaded Pellets depend on:
Published research on starch-based pellets shows that the choice of starch and formulation additives can influence pellet structure and the resulting release profile.
Therefore, finished-pellet assay, starch loading, moisture, density, friability and release parameters should remain product-specific unless supported by the SDP product specification or COA.
Starch-Loaded Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Starch loading, pellet size, moisture, density, formulation composition, packaging configuration and finished-product acceptance criteria should be confirmed against the applicable SDP product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |